MAUDE Adverse Event Report: CAREFUSION ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING; SET, EXTENSION, INTRAVASCULAR

Model Number	30893-07
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that the epidural tubing leaked which causes delay of treatment.There was no harm to patient.
Event or Problem Description
It was reported that the epidural tubing leaked, which causes a delay of treatment.It was confirmed during follow up, that there was no patient harm or impact as a result of this event.
Additional Manufacturer Narrative
The customer¿s report that the epidural tubing leaked was confirmed.The sets were visually inspected for obvious damage such as incomplete bonding engagements, cracks, fractures, kinks, holes, and tears in the tubing and its components.A residual clear, colorless liquid was present within the set.No anomalies or evidence of damages were observed upon initial visual inspection.The leak occurred at the engagement between the microbore tubing and the male luer adapter.Further observation under microscope revealed some solvent anomalies that seemed more evident along the area of the yellow stripe of the microbore tubing.Functional testing was performed; small droplets were observed at the engagement between the tubing and the inlet port of the male luer.The set was then pressure tested; a leak at the engagement between the tubing to the distal male luer adapter was observed.The root cause that the epidural tubing leaked was a manufacturing issue.

• Brand Name: ALARIS PCEA ADMINISTRATION SET MICROBORE TUBING
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9405122
• Report Number: 9616066-2019-03509
• Device Sequence Number: 3232189
• Product Code: FPA
• UDI-Device Identifier: 10885403460234
• UDI-Public: 10885403460234
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2020
• Device Model Number: 30893-07
• Device Catalogue Number: 30893-07
• Device Lot Number: 17096818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0386-2019
• Patient Sequence Number: 1
• Patient Age: 14 YR